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This ICH guideline gives guidance on the basic testing protocol required to evaluate the light sensitivity and stability of new drugs and products.
August 2003. CPMP/ICH/2736/99. ICH Topic Q 1 A (R2). Stability Testing of new Drug Substances and Products. Step 5. NOTE FOR GUIDANCE ON STABILITY TESTING: The texts on test procedures etc. have been brought in line with the Q6A guideline. .. conditions for photostability testing are described in ICH Q1B.
30 Sep 2014 ICH GUIDELINES. Q1B: Photostability Testing of New Drug Substances and Products • Give guidance on the basic testing protocol required to evaluate the light . Q6 : Specifications for New Drug Substances and Products • Bulk drug substance and final product specifications are key parts of the core
Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management. Zip with all ICH Quality Guidelines in
ICH HARMONISED TRIPARTITE GUIDELINE. SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA. FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS: CHEMICAL SUBSTANCES. Q6A. Current Step 4 version dated 6 October 1999. This Guideline has been developed by the appropriate
2 Jan 2010 Current Step 4 version dated 6 February 2003. This Guideline has been developed by the appropriate ICH Expert Working Group and .. described in ICH Q1B. Examining degradation products under stress acceptance criteria, is addressed in ICH Q6A and Q6B. In addition, specification for degradation
ICH HARMONISED TRIPARTITE GUIDELINE. STABILITY TESTING: PHOTOSTABILITY TESTING OF. NEW DRUG SUBSTANCES AND PRODUCTS. Q1B. Current Step 4 version dated 6 November 1996. This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation
       

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